Intrawound Administration of Vancomycin in THA

Qingdao University

Status: Completed

Conditions: Hip

Treatments: Procedure: Intrawound administration of vancomycin after closure of the arthrotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05338008

AHQingdao VancoTHA

Details and patient eligibility

About

The purpose of this study is to determine the intra-articular and serum levels of vancomycin over the first 24 hours postoperatively after intra-articular administration of a standard dose of vancomycin in primary total hip arthroplasty.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age over 18;
2. Total hip arthroplasty for advanced hip diseases including femoral neck fracture, developmental dysplasia of hip, and osteonecrosis of the femoral head.

Exclusion criteria

1. Diminished mental capacity
2. Vancomycin allergy
3. Chronic kidney disease stage III and stage IV

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Intrawound Administration of Vancomycin

Experimental group

Description:

After closure of the arthrotomy, 1 g of vancomycin powder suspended in 30ml of normal saline was injected directly into the joint with an 18-gauge needle. Then 20ml of normal saline was injected directly into the joint.

Treatment:

Procedure: Intrawound administration of vancomycin after closure of the arthrotomy

Intrawound Administration of Vancomycin combined with epsilon-aminocaproic acid (EACA)

Experimental group

Description:

After closure of the arthrotomy, 1 g of vancomycin powder suspended in 30ml of normal saline was injected directly into the joint with an 18-gauge needle. Then 4g (20ml) of epsilon-aminocaproic acid (EACA) was injected directly into the joint.

Treatment:

Procedure: Intrawound administration of vancomycin after closure of the arthrotomy

Intrawound Administration of epsilon-aminocaproic acid (EACA)

No Intervention group

Description:

After closure of the arthrotomy, 30ml of normal saline was injected directly into the joint with an 18-gauge needle. Then 4g (20ml) of epsilon-aminocaproic acid (EACA) was injected directly into the joint.